Frankfurt Higher Regional Court upholds BESREMi ® arbitral award in favor of AOP Health

Today, the Higher Regional Court of Frankfurt upheld the February 2025¹ partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages.

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Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.”

The Product in Dispute

The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into an innovative treatment for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines². AOP Health had acquired the rights for both BESREMi®’s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory.

First Arbitration and Set-aside Proceedings

Since 2017, PharmaEssentia repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health approx. EUR 143 million in damages and dismissed PharmaEssentia’s counterclaims in its entirety.

Subsequent set-aside proceedings confirmed the arbitral award in its essentials, but found procedural flaws with respect to damage quantification, impacting the damages awarded.

Second Arbitration

In November 2020, PharmaEssentia initiated a legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia, and the misuse of AOP Health’s clinical trial data for PharmaEssentia’s US marketing authorization. The result was a partial final ICC arbitral award in favor of AOP Health, received on 17 February 2025, which found PEC guilty of intentional breaches and liable for several claims. The tribunal’s decision on the quantum of those claims is yet to be made.

Ruling of Higher Regional Court of Frankfurt Confirms AOP Health’s Position

In May 2025, PharmaEssentia filed an application with the Frankfurt Higher Regional Court to set aside the partial final ICC arbitral award dated 10 February 2025, arguing among other things that the award violated public order and PharmaEssentia’s right to be heard.

On 24 April 2026, the Frankfurt Higher Regional Court dismissed this application in its entirety and declared the award enforceable. An appeal to the German Federal Court of Justice is possible.

AOP Health believes this decision confirms its position and reinforces its commitment to patients. The company will continue to supply patients in need of ropeginterferon alfa-2b (BESREMi®), maintaining the high standards of quality patients depend on.

About BESREMi®

BESREMi® is the first interferon that was approved for polycythemia vera, a myelo­proliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies.

BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen.

For the EMA Summary of Product Characteristics please visit: BESREMi®

About AOP Health

AOP Health is a global healthcare group with roots in Austria, where the headquarters of AOP Orphan Pharmaceuticals GmbH ("AOP Health") is located. Since 1996, the AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the fields of rare diseases and intensive care medicine.

At the end of 2024, AOP Health received its first U.S. FDA approval for Rapiblyk^TM, a medication aimed at patients in intensive care units, thereby further strengthening its commitment to making therapies available for patients worldwide. The AOP Health Group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners.

With the claim "Needs. Science. Trust." the AOP Health Group emphasizes its commitment to research and development, as well as the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of the AOP Health Group’s actions.

¹https://www.aop-health.com/global_en/press/press-releases/icc-arbitral-tribunal-ruling-aop-health/

² ELN Guideline (2022), NCCN Guideline (2024), Onkopedia Leitlinie (2023)

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